NCT07102654

Brief Summary

The goal of this prospective observational study is to assess the post-operative pain in adults with digital amputation following two different surgical interventions: microanastomosis of digital nerves or traction neurectomy. The main questions it aims to answer are:

  • Which surgical intervention results in less post-operative pain?
  • Which surgical intervention leads to fewer symptoms after six months?
  • Which surgical intervention is associated with fewest post-operative complications? Participants will complete a Visual Analog Scale (VAS) to assess the pain and the Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH) to evaluate the disabilities. The researchers will assess post-operative complications during follow-up appointments.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
2mo left

Started Dec 2025

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress75%
Dec 2025Jul 2026

First Submitted

Initial submission to the registry

July 30, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 5, 2025

Completed
4 months until next milestone

Study Start

First participant enrolled

December 1, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Last Updated

September 15, 2025

Status Verified

July 1, 2025

Enrollment Period

7 months

First QC Date

July 30, 2025

Last Update Submit

September 11, 2025

Conditions

Keywords

microanastomosistraction neurectomydigital amputationdigital nerve

Outcome Measures

Primary Outcomes (2)

  • Postoperative Pain Measured by Visual Analog Scale in Adult Patients Following Digital Amputation

    The primary objective of this study is to compare the level of postoperative pain associated with two surgical techniques: microanastomosis of digital nerves and traction neurectomy. Pain will be measured using the visual analog scale at one week, four weeks, and six months following the procedure. The visual analog scale ranges from 0 ( no pain) to 10 (worst imaginable pain).

    1 week, 4 weeks and 6 months

  • Postoperative Symptoms Measured by the Disabilities of the Arm, Shoulder and Hand Questionnaire in Adult Patients Following Digital Amputation

    The secondary objective of this study is to compare the level of postoperative symptoms associated with two surgical techniques: microanastomosis of digital nerves and traction neurectomy. The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire will assess disability and hand-related symptoms at 6 months. The score ranges from 0 (no disability) to 100 (most severe disability)

    6 months

Secondary Outcomes (1)

  • Complication Rate of Microanastomosis of Digital Nerves and Traction Neurectomy in Adult Patients Following Digital Amputation

    1 week, 4 weeks, 6 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Individuals presenting at the Centre Hospitalier de l'Université de Montréal for a digital amputation

You may qualify if:

  • Age ≥ 18 years
  • Patients who have undergone a traumatic digital amputation
  • Patients treated with one of the two following techniques: microanastomosis of digital nerves or traction neurectomy
  • Postoperative follow-up of at least 6 months

You may not qualify if:

  • Patients treated with a surgical intervention other than microanastomosis of digital nerves or traction neurectomy for digital amputation
  • Non-traumatic amputations (e.g., cancer or infection)
  • Follow-up of less than 6 months
  • Patients with pre-existing peripheral neuropathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 30, 2025

First Posted

August 5, 2025

Study Start

December 1, 2025

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

September 15, 2025

Record last verified: 2025-07